Sodium Oxybate (Xyrem)

SELF ADMINISTERED

FDA Approved Indications:

  • For the treatment of cataplexy in narcolepsy
  • For the treatment of excessive daytime sleepiness in narcolepsy

Coverage is Not Authorized For:

  • Fibromyalgia
  • Use in combination with sedative hypnotics or alcohol
  • Non-FDA approved indications, unless there is sufficient documentation of efficacy and safety in the published literature

General Information:

  • Contraindicated in patients using alcohol or sedatives
  • Available through the Xyrem Success Program using a centralized pharmacy 1-866-XYREM88

Recommended Dosing Regimen and Authorization Limit:

  • The recommended starting dose is 4.5 gm/day PO divided into two equal doses
  • Increase the dosage in increments of 1.5 gm/day at two-week intervals to a maximum of 9 gm/day

Availability:

  • Oral Solution: 500 mg/mL, 180 mL bottles

Approval:

  • Initial approval 3 months to assess patient's response
  • Continued authorization for 1 year